MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. TERUMO ADVANCED PERFUSION SYSTEM 1; APS 1 (CCM)

Model Number 816300

Device Problems Bent (1059); Blocked Connection (2888)

Patient Problem Not Applicable (3189)

Event Date 01/14/2014

Event Type  malfunction  

Event Description

The service repair tech (srt) reported that during routine testing of the device at the service center, the power cable assembly had loose, pushed in and bent pins (that plug into base connector).There was no pt involvement.

Manufacturer Narrative

Eval is in progress, but not yet concluded.

• Brand Name: TERUMO ADVANCED PERFUSION SYSTEM 1
• Type of Device: APS 1 (CCM)
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• Manufacturer (Section G): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 6200 jackson rd.; ann arbor MI 48103
• Manufacturer Contact: jan winder ; 6200 jackson rd.; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 3752947
• MDR Text Key: 17614685
• Report Number: 1828100-2014-00058
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022947
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 816300
• Device Catalogue Number: 816300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/14/2014
• Initial Date FDA Received: 02/05/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1